The following data is part of a premarket notification filed by Epcom Medical Systems, Inc. with the FDA for 1uro-log Home Diagnostic Pack.
| Device ID | K844338 |
| 510k Number | K844338 |
| Device Name: | 1URO-LOG HOME DIAGNOSTIC PACK |
| Classification | Device, Urine Flow Rate Measuring, Non-electrical, Disposable |
| Applicant | EPCOM MEDICAL SYSTEMS, INC. 26602 CORPORATE AVE. Hayward, CA 94545 |
| Contact | Paul Ulbrich |
| Correspondent | Paul Ulbrich EPCOM MEDICAL SYSTEMS, INC. 26602 CORPORATE AVE. Hayward, CA 94545 |
| Product Code | FFG |
| CFR Regulation Number | 876.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-08 |
| Decision Date | 1985-02-25 |